INmune Bio Reveals Interim Phase 2 Alzheimer's Trial Results Linking EMACC and CDR-SB

INmune Bio Inc. (NASDAQ: INMB), based in Boca Raton, Florida, announced significant findings from its AD02 Phase II Alzheimer's Disease (AD) trial. The company, known for its work in immunology and inflammation, revealed that its novel cognitive measure, EMACC, demonstrated exceptional performance and a strong correlation with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a standard endpoint for AD trials.

Judith Jaeger, Ph.D., a renowned neuropsychologist who collaborated in developing EMACC, commented on the findings. She noted that EMACC was empirically designed to measure cognitive changes in early AD patients accurately. Unlike CDR-SB, which relies on subjective assessment and was initially a staging tool, EMACC provides an objective measure of cognitive decline, making it a more precise tool for evaluating cognitive function.

Key findings from the AD02 trial included a highly significant correlation between baseline scores on EMACC and CDR-SB, confirmed by an independent review. The correlation coefficient between EMACC during the screening process and at the first study visit before treatment was 0.93, indicating high reliability. Additionally, EMACC showed a substantial differentiation capability, with a large effect size when distinguishing between patients with different AD stages, highlighting its sensitivity and precision.

C.J. Barnum, Ph.D., VP of Neuroscience at INmune, emphasized that the AD02 trial's novel design elements significantly reduce risk compared to traditional AD drug development trials. He highlighted that EMACC's precise measurement capabilities and its link to biomarkers of inflammation are crucial for patient enrollment in the trial. Barnum expressed optimism about completing patient enrollment by the end of the quarter and releasing topline data about six months afterward.

EMACC, an empirically derived cognitive measure, consists of standardized neuropsychological tests that have shown high sensitivity to changes in early AD patients over a two-year follow-up period. Its performance characteristics were first reported by Biogen at CTAD in 2021. Additionally, EMACC has been strongly associated with biological markers of inflammation in the Alzheimer's Disease Neuroimaging Initiative (ADNI) study.

These findings firmly establish EMACC's suitability as a primary endpoint in early AD studies.

Judith Jaeger, Ph.D., the principal developer of EMACC, is the founder of CognitionMetrics, a leading neurocognition consulting firm. With over two decades of experience, Dr. Jaeger is an internationally recognized expert in designing cognitive function testing programs for clinical trials.

INmune Bio Inc. is a clinical-stage biotechnology company specializing in inflammation and immunology. Its research focuses on treatments targeting the innate immune system to combat various diseases. INmune Bio's product platforms include the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform, which aims to neutralize soluble TNF, a key driver of immune dysfunction. This platform is currently in clinical trials for conditions such as cancer, early Alzheimer's disease, and treatment-resistant depression. Moreover, the company's Natural Killer Cell Priming Platform includes INKmune™, designed to prime patients' NK cells to eliminate residual disease in cancer patients.

INmune Bio's approach to developing treatments involves precision medicine, aiming to address a wide range of hematologic and solid tumor malignancies, as well as chronic inflammation.